Medtronic Infuse is an artificial bone graft intended to treat degenerative disc disease, a condition that often leads to pain, stiffness and soreness in the lower back. As such, it is approved by the U.S. Food and Drug Administration (FDA) for spinal procedures performed through the anterior (front) of the body from the L4 to S1 region. However, Infuse was often used for unapproved procedures, or “off-label”-particularly in the cervical spine. Doctors are allowed to use drugs and medical devices off-label at their discretion, but it is illegal for manufacturers to promote their products for these uses.
In July 2008, the U.S. Food and Drug Administration (FDA) warned about the potentially fatal effects of using Infuse in the cervical spine. Using Infuse in this manner could lead to swelling of the neck and throat, compressing the airway and neurological structures, the agency had said.
Infuse has been involved in both personal injury and shareholder litigation. In 2009, shareholder lawsuit alleged that Medtronic marketed Infuse for off-label uses, and falsely inflated its stock values by failing to disclose the fact that a large part of its revenue is generated through off-label procedures.
Last June, the Spine Journal cast a critical light on the data supporting the safety of Infuse. According to the publication, researchers omitted side effects such as cancer, retrograde ejaculation, male sterility, infections, bone dissolution, and worsened back and leg pain.